Actively Recruiting
The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
Led by Tuba Eryiğit · Updated on 2026-04-16
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of cold salt water and unsalted cold water foot baths on preventing chemotherapy-induced peripheral neuropathy (CIPN) in women with breast cancer receiving paclitaxel chemotherapy. The study aims to reduce the development, severity, and impact of CIPN symptoms on daily life and activities by comparing the salt water foot bath, unsalted water foot bath, and standard clinical care. This is a prospective, randomized, controlled trial led by Tuba Eryiit. Participants are divided into three groups: one receives a cold salt water foot bath with 175 grams of salt at 22 degrees Celsius, another receives an unsalted cold water foot bath at 22 degrees Celsius, and a control group receives standard clinical care information. Both foot bath groups undergo 30 minutes of application during the three-hour paclitaxel treatment, repeated four times with 10-minute breaks in between, across 12 weekly chemotherapy cycles. The control group receives usual care information once and may choose a foot bath method after the study ends. Throughout the 12-week treatment period, all participants are evaluated before each chemotherapy cycle using the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and the Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT). At the end of the 12th cycle, vibration and monofilament tests assess neuropathy. Researchers measure CIPN development, symptom severity, frequency, and impact on daily life to determine the effectiveness of the foot bath interventions in preventing CIPN.
CONDITIONS
Brief Title
The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 and over
- Conscious
- Speak and understand Turkish
- Diagnosed with breast cancer
- Scheduled to receive paclitaxel chemotherapy
- Answered 'no' to section 'A' of the CIPNAT scale
You will not qualify if you...
- Abnormal vibration test indicating neuropathy
- Reduced pressure sensation in one or none of three areas on the foot by monofilament test
- Existing chemotherapy-associated peripheral neuropathy
- Diagnosed with diabetes
- Open wounds or skin ulcers on the foot
- Peripheral or central nervous system disease
- Peripheral vascular disease
- Presence of bone or soft tissue metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks (during 12 paclitaxel treatment cycles)
Participants receive cold salt water foot baths, cold unsalted water foot baths, or standard care during their paclitaxel chemotherapy sessions. They will have evaluations for peripheral neuropathy before each chemotherapy cycle.
12 visits before each chemotherapy cycle
Duration - At the end of 12th cycle
Participants undergo vibration and monofilament tests to assess peripheral neuropathy at the end of the 12th chemotherapy cycle.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Haydarpaşa Numune Training and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye), 34668
Actively Recruiting
Research Team
T
Tuba Eryigit, PhD student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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